1. Product Identification
Product Name: Piperacillin Sodium / Sulbactam Sodium API
Ratio: Typically Piperacillin : Sulbactam = 2:1 (or customized as required)
Pharmacopoeia Reference: USP, EP, CP
Usage: For manufacture of injectable finished pharmaceuticals (powder for injection)
2. Quality Specification Standards
bn
White to off‑white crystalline powder; hygroscopic.
Identification
IR: Consistent with reference standard
HPLC: Retention time of sample peak matches reference standard
Assay (on dried basis)
Piperacillin Sodium: 92.0% – 108.0%
Sulbactam Sodium: 91.0% – 109.0%
pH
5.0 – 6.0 (20 mg/mL aqueous solution)
Specific Rotation
Piperacillin sodium part: + 175° to + 195°
Sulbactam sodium part: + 20° to + 30°
Water Content
≤ 2.0% (Karl Fischer method)
Bacterial Endotoxins
< 0.10 EU/mg (sterile API grade)
Related Substances (HPLC)
Total impurities: ≤ 2.0%
Single maximum unknown impurity: ≤ 1.0%
Heavy Metals
≤ 20 ppm
Sterility
Complies with sterility test (sterile grade)
Particle Size Distribution
Customizable for injectable formulation requirements
3. Key Characteristics
Combined β‑lactam antibiotic + β‑lactamase inhibitor API
Broad‑spectrum activity against Gram‑positive and Gram‑negative bacteria
Effective against β‑lactamase‑producing resistant strains
Low endotoxin, suitable for injectable preparation
Strict GMP production & full traceability
Stable under recommended storage conditions
4. Storage
Sealed, preserved in a dry, cool place, protected from light and moisture.
Temperature: 2°C – 8°C recommended for long‑term storage.
5. Packaging
Aluminum foil bag / fiber drum / PE drum
Net weight: 1 kg, 5 kg, 10 kg, 25 kg (customizable)